Benign prostatic hyperplasia treatment device

ABSTRACT

Disclosed herein is a benign prostatic hyperplasia treatment device. The benign prostatic hyperplasia treatment device includes: anchor assemblies including a first anchor arranged at the outer surface of the prostate gland, which obstructs the prostatic urethra, a second anchor arranged inside the prostate gland to be opposed to the first anchor, and a ligature connecting the first anchor and the second anchor with each other so that the second anchor compresses the prostate tissue to secure the opening of the prostatic urethra; and a sheath inserted into the urethra and having a needle, which guides the anchor assembly to be deployed at the prostate gland.

TECHNICAL FIELD

The present invention relates to a benign prostatic hyperplasiatreatment device, and more particularly, to a benign prostatichyperplasia treatment device, which can continuously open the prostaticurethra by ligating an enlarged prostate after pushing the enlargedprostate out of the urethra.

BACKGROUND ART

In general, benign prostatic hyperplasia is a symptom that causes theprostate to become enlarged abnormally and causes urethrophraxis sincethe abnormally enlarged prostate blocks the prostatic urethra below thebladder, so that urine is not excreted smoothly.

A person who has the benign prostatic hyperplasia experiences greatinconveniences in his daily life due to various symptoms, such asfrequent urination, urination at night, weak urinary stream, feeling ofresidual urine, and others.

In order to treat such benign prostatic hyperplasia, a benign prostatichyperplasia treatment method illustrated in FIG. 1 has been carried out.

When the benign prostatic hyperplasia occurs, as shown in FIG. 1(a), apair of prostate lobes A and B enlarges at both sides of the urethra Cand blocks the urethra C. As shown in FIG. 1(b), an operator inserts acystoscope 10 into the urethra, inserts a medical ligator 11 disposed atan end portion of the cystoscope 10 through the prostate lobes A and Bas shown in FIG. 1(c), puts a first implant 20 at an upper portion ofthe left prostate lobe A as shown in FIG. 1(d), and puts a secondimplant 20 a at an upper portion of the right prostate lobe B as shownin FIG. 1(e).

After that, as shown in FIG. 1(f), the operator puts a third implant 20b and a fourth implant 20 c respectively at a lower portion of the leftprostate lobe A and a lower portion of the right prostate lobe B.

In this instance, the implants 20, 20 a, 20 b and 20 c have externalimplants 21 arranged on the outside of the prostate lobes A and B andinternal implants 23 arranged near the urethra. Each of the externalimplants 21 and each of the internal implants 23 are connected to eachother by a ligature 25, and the internal implants 23 compress theprostate lobes A and B outwards based on the length of the ligature 25in order to open the urethra.

However, such a benign prostatic hyperplasia treatment method has adisadvantage in that the area of the prostate tissue compressed by oneimplant 20 is limited to the size of the internal implant 23.

Moreover, the prostate tissue (a) between the internal implant at theupper portion and the internal implant at the lower portion is notcompressed but still remains in the enlarged state toward the urethrasince there is an interval between the implant 20 arranged at the upperportion and the implant 20 b arranged at the lower portion, so that theprostate tissue is not compressed continuously but just a part abuttingthe internal implant 23 is compressed partially.

PATENT LITERATURE Patent Documents

-   Patent Document 1: Korean Patent No. 10-1534820 entitled “Implant    for treating benign prostatic hyperplasia”-   Patent Document 2: U.S. patent Ser. No. 10/349,932 entitled “Anchor    delivery system”

DISCLOSURE Technical Problem

Accordingly, the present invention has been made in an effort to solvethe above-mentioned problems occurring in the prior arts, and it is anobject of the present invention to provide a benign prostatichyperplasia treatment device that can adjust an area of compression by apair of anchors arranged at upper and lower portions of the prostatelobe and connected with each other by a ligature. It is another objectof the present invention to provide a benign prostatic hyperplasiatreatment device that can adjust the length of the ligature thatconnects a pair of the anchors in order to continuously compress theprostate gland according to patients' prostate sizes.

Technical Solution

To achieve the above objects, the present invention provides a benignprostatic hyperplasia treatment device including: anchor assembliesincluding a first anchor arranged at the outer surface of the prostategland, which obstructs the prostatic urethra, a second anchor arrangedinside the prostate gland to be opposed to the first anchor, and aligature connecting the first anchor and the second anchor with eachother so that the second anchor compresses the prostate tissue to securethe opening of the prostatic urethra; and a sheath inserted into theurethra and having a needle, which guides the anchor assembly to bedeployed at the prostate gland.

Moreover, the benign prostatic hyperplasia treatment device furtherincludes: a needle manipulation part for manipulating movement of theneedle so that the needle is deployed through an end portion of thesheath; a thread winder disposed at one side of the needle manipulationpart and winding the ligature thereon to adjust intensity with which theanchor assemblies compress the prostate gland; and a handle frame partwhich supports the end portion of the sheath, the needle manipulationpart and the thread winder and is grasped by an operator, wherein theligature includes: a length-adjustable loop joined to the first anchorand the second anchor to be adjustable in length; a free end extendingfrom the length-adjustable loop; and a slip knot for connecting thelength-adjustable loop to the free end so as to adjust the length of thelength-adjustable loop.

Furthermore, the thread winder winds the free end to adjust the lengthof the length-adjustable loop so that the second anchor compresses theprostate tissue.

Advantageous Effects

Compared with the conventional benign prostatic hyperplasia treatmentdevice which partially compresses the prostate tissues, the benignprostatic hyperplasia treatment device according to the presentinvention has an advantage in that urine flow rate increases since theprostate tissue compressed by the ligature and a pair of the anchors iscontinuous, and is more effective for patients who have a large prostategland.

Furthermore, the benign prostatic hyperplasia treatment device accordingto the present invention has another advantage in that the operator canadjust intensity with which to compress the prostate gland as much asthe operator wants since the operator adjusts the length of the ligatureby winding a free end of the ligature.

Therefore, the benign prostatic hyperplasia treatment device accordingto the present invention can adjust the compression level according tovarious symptoms of benign prostatic hyperplasia presented by patients.

A treatment method using the benign prostatic hyperplasia treatmentdevice according to the present invention does not need generalanesthesia or long operation time like laser surgery or electricalsurgery using thermal energy.

Additionally, the benign prostatic hyperplasia treatment deviceaccording to the present invention makes quick operation time and localanesthesia possible through a simple anchor installation method, and isnot accompanied by side effects, such as retrograde ejaculation,impotence or hematuria, since the prostate tissues are not resected. Inaddition, because the benign prostatic hyperplasia treatment deviceaccording to the present invention is minimally invasive, if it isineffective, a patient can have another operation any time.

DESCRIPTION OF DRAWINGS

FIG. 1 is an exemplary view showing a conventional benign prostatichyperplasia treatment method.

FIG. 2 is a perspective view showing a structure of a benign prostatichyperplasia treatment device according to an embodiment of the presentinvention.

FIGS. 3 to 5 are exploded perspective views showing the structure of thebenign prostatic hyperplasia treatment device according to theembodiment of the present invention.

FIG. 6 is a side view showing a lateral structure of the benignprostatic hyperplasia treatment device according to the embodiment ofthe present invention.

FIG. 7 is a perspective view showing a structure of an anchor assemblyof the benign prostatic hyperplasia treatment device according to theembodiment of the present invention.

FIG. 8 is an exemplary view showing a state where the anchor assembly ofthe benign prostatic hyperplasia treatment device according to theembodiment of the present invention is deployed at a left prostate lobe.

FIG. 9 is a view showing a structure of a needle guide member of thebenign prostatic hyperplasia treatment device according to theembodiment of the present invention.

FIG. 10 is a perspective view showing an external structure of a handleframe part of the benign prostatic hyperplasia treatment deviceaccording to the embodiment of the present invention.

FIG. 11 is a perspective view showing a structure of a needlemanipulating part of the benign prostatic hyperplasia treatment deviceaccording to the embodiment of the present invention.

FIG. 12 is an exemplary view showing a manipulation process of a needletrigger of the benign prostatic hyperplasia treatment device accordingto the embodiment of the present invention.

FIG. 13 is a view showing a structure of a thread winder of the benignprostatic hyperplasia treatment device according to the embodiment ofthe present invention.

FIG. 14 is an exemplary view showing an operation of a winder gear ofthe thread winder of the benign prostatic hyperplasia treatment deviceaccording to the embodiment of the present invention.

FIGS. 15 to 17 are exemplary views showing a use process of the benignprostatic hyperplasia treatment device according to the embodiment ofthe present invention.

FIGS. 18 and 19 are exemplary views schematically showing a treatmentprocess of benign prostatic hyperplasia using the benign prostatichyperplasia treatment device according to the embodiment of the presentinvention.

FIG. 20 is a view showing an anchor assembly of a benign prostatichyperplasia treatment device according to a first modification of thepresent invention.

FIG. 21 is an exemplary view showing a treatment process of the anchorassembly according to the first modification of the present invention.

FIG. 22 is an exemplary view showing a state where the anchor assemblyof the benign prostatic hyperplasia treatment device according to thefirst modification of the present invention is deployed at the leftprostate lobe.

FIG. 23 is a view showing anchor assemblies of according to a secondmodification and a third modification of the present invention.

FIG. 24 is an exemplary view showing a state where the anchor assemblyaccording to the second modification of the present invention isdeployed at the left prostate lobe and a state where the anchor assemblyaccording to the third modification of the present invention is deployedat the left prostate lobe.

FIG. 25 is a view showing an anchor assembly of according to a fourthmodification of the present invention.

FIG. 26 is an exemplary view showing a state where the anchor assemblyaccording to the fourth modification of the present invention isdeployed at the left prostate lobe.

MODE FOR INVENTION

Hereinafter, preferred embodiments of the present invention will now bedescribed in detail with reference to the attached drawings, in whichlike reference numbers denote corresponding parts throughout thedrawings.

The terms “comprising” and “including” in the discussion directed to thepresent invention and the claims are used in an open-ended fashion andthus should be interrupted to mean “including”, but not limited thereto.

FIG. 2 is a perspective view showing a structure of a benign prostatichyperplasia treatment device 1 according to an embodiment of the presentinvention, FIGS. to 5 are exploded perspective views showing thestructure of the benign prostatic hyperplasia treatment device 1according to the embodiment of the present invention, and FIG. 6 is aside view showing a lateral structure of the benign prostatichyperplasia treatment device 1 according to the embodiment of thepresent invention.

The benign prostatic hyperplasia treatment device 1 according to theembodiment of the present invention includes: a handle frame part 100that fixes each of the components and an operator grips with the hand;an anchor assembly 200 which is deployed at the prostate lobes A and Bto open the urethra by compressing the prostate tissues blocking theurethra; a sheath 300 which extends from the front end of the handleframe part 100 to a predetermined length and is inserted into theurethra (C) to guide a needle 350 accommodated therein so that an anchorassembly 200 is deployed at the prostate lobes A and B; a needlemanipulating part 400 which is disposed in the handle frame part 100 toadjust the position of the needle 350 and is manipulated by the operatorso that the anchor assembly 200 comes out of the needle 350; and athread winder 500 which is rotatably disposed in the handle frame part100 to wind a ligature 230 of the anchor assembly 200 and adjusts thelength of the ligature 230 so that the anchor assembly 200 compressesthe prostate lobes A and B.

The benign prostatic hyperplasia treatment device 1 according to theembodiment of the present invention can continuously compress theprostate gland, which obstructs the urethra, with compression leveldesired by the operator using a pair of the anchor assemblies 200.Therefore, the benign prostatic hyperplasia treatment device 1 accordingto the embodiment of the present invention can adjust the length and thedepth of compression to the prostate gland according to symptoms ofbenign prostatic hyperplasia presented by patients, and can increaseurine flow rate.

As shown in FIGS. 2 to 4, the handle frame part 100 is combined with therear of the sheath 300 and contains the needle manipulating part 400therein. The operator can manipulate the sheath 300 and the needlemanipulating part 400 with the handle frame part 100 in his or her handin order to insert the sheath 300 into the urethra, and then, adjust thepositions of the needle 350 and the anchor assembly 200 in order todeploy the anchor assembly 200 at the prostate gland.

The handle frame part 100 is formed by a releasable combination of aleft frame 110 and a right frame 120 which are respectively arranged atthe left and the right. The left frame 110 and the right frame 120 aregenerally formed in a handle shape to be grasped in the hand.

Needle manipulating part receiving grooves 111 are formed on internalplate surfaces of the left frame 110 and the right frame 120 to apredetermined depth so that the position of the needle manipulating part400 can be fixed between the left frame 110 and the right frame 120.Moreover, a needle holder 410 of the needle manipulating part 400 canmove forwards and backwards stably inside the needle manipulating partreceiving groove 111.

A thread winder receiving recess 113 is formed at an upper portion ofthe needle manipulating part receiving groove 111 to be hollow to apredetermined depth relative to the plate surface. As shown in FIG. 4, awinder gear 530 of the thread winder 500 is accommodated in the threadwinder receiving recess 113. A shaft hole 113 c into which a windershaft 510 is inserted is bored into the bottom surface of the threadwinder receiving recess 113, and a winder fixing groove 113 a and alimit bar receiving groove 113 b are formed on the outer circumferentialsurface of the thread winder receiving recess 113 outwardly in a radialdirection.

A position fixing protrusion 537 a of a thread guide cap 537 of thewinder gear 530 is accommodated in the winder fixing groove 113 a.Therefore, the winder gear 530 is rotated inside the thread winderreceiving groove 113, and the thread guide cap 537 is not rotated but isfixed in its position.

A one-way rotation limit bar 540 of the thread winder 500 isaccommodated in the limit bar receiving groove 113 b to limit therotational direction so that the winder gear 530 rotates in just onedirection.

The shaft hole 113 c is bored into the bottom surface of the winderfixing groove 113 a. The winder shaft 510 of the thread winder 500 isinserted into the shaft hole 113 c.

The left frame 110 and the right frame 120 respectively include pushermovement slits 112 and 121 formed in the opposite direction to eachother, blade button movement slits 114 and 123 formed in the oppositedirection to each other, and locking member movement grooves 115 and 125formed in the opposite direction to each other. As shown in FIG. 2, apusher button 366 is extended outwards from the pusher movement slits112 and 121 to a predetermined length, a blade pressing button 375 isextended outwards from the blade button movement slits 114 and 123 to apredetermined length, and a trigger locking member 440 is extendedoutwards from the locking member movement grooves 115 and 125 to apredetermined length.

The operator presses the pusher button 366 and the trigger lockingmember 440, which are extended from both sides of the left frame 110 andthe right frame 120 to the predetermined length, with his or her hand inorder to simply adjust the position of the needle 350 and the positionof the anchor assembly 200 by adjusting positions of the pusher button366 and the trigger locking member 440 back and forth, and manipulatesthe blade pressing button 375 to cut a free end 237.

In the meantime, lever movement paths 116 and 126 are respectivelyformed at the front of the left frame 110 and at the front of the rightframe 120 in order to guide back-and-forth movement of a pulling lever413 of a needle holder 410 of the needle manipulating part 400.

Furthermore, endoscope insertion holes 117 and 127 into which atransurethral endoscope is inserted are respectively formed at the rearof the left frame 110 and at the rear of the right frame 120 so that theoperator can inspect the inside of the prostate gland during a surgicaloperation.

The anchor assembly 200 is deployed at the prostate gland of the patientand compresses the prostate gland so that the urethra is opened. When apair of the anchor assemblies 200 is deployed at the left prostate lobeA and the right prostate lobe B, the medical operation using the benignprostatic hyperplasia treatment device 1 according to the embodiment ofthe present invention is finished. FIG. 7 is a perspective view showingstructure of one anchor assembly 200, and FIG. 8 is an exemplary viewshowing a state after the anchor assembly 200 is deployed at a leftprostate lobe A and before the length is adjusted.

As shown in FIG. 7(a), the anchor assembly 200 includes the first anchor210, the second anchor 220, and the ligature 230 for connecting thefirst anchor 210 and the second anchor 220 with each other. The firstanchor 210 is formed in a hollow tube shape. A first thread hole 211 anda second thread hole 213 into which the ligature 230 is inserted areformed in the surface of the first anchor 210. The second thread hole213 has bent slits 215 of a predetermined length formed at both sidesthereof. By the bent slits 215, a bent plate 217 is bent to be inclinedat a predetermined angle and the second thread hole 213 is expanded insize.

The ligature 230 is inserted into the first thread hole 211, and then,is passed through the second thread hole 213. In this instance, becausethe internal space of the first anchor 210 is narrow, it is not easy topass the ligature 230 inserted into the first thread hole 211 throughthe second thread hole 213. Therefore, the bent plate 217 is bent by thebent slits 215 and the second thread hole 213 is expanded, so that theligature 230 can be passed through easily.

The first anchor 210 and the second anchor 220 are made of metal ormetal alloy, are preferably made of nitinol and have the same structure.The first anchor 210 and the second anchor 220 are bent by the bentslits 215, but as shown in FIG. 16(a), are elastically transformedaccording to the shape of the needle 350 when being accommodated in theneedle 350. As shown in FIG. 16(b), the bent plates 217 and 227 arereturned to their original state when the first anchor 210 and thesecond anchor 220 are outside the needle 350.

The bent plate 217 is bent relative to the outer surface of the firstanchor 210 due to the bent slit 215, and prevents the first anchor 210located on the outer surface of the prostate gland from moving reverselythrough the hole in the prostate gland formed by the needle 350.

That is, during the surgical operation, when the needle 350 pierces theprostate lobe A and puts the first anchor 210 outside the prostate lobeA, the first anchor 210 is bent as the bent plate 217 is bentelastically. The bent first anchor 210 is caught by the hole in theprostate gland formed by the needle 350 and is prevented from thereverse movement, and then, is put on the surface of the prostate lobe Astably.

The ligature 230 connects the first anchor 210 and the second anchor 220with each other in such a way as to be adjustable in length. The firstanchor 210 and the second anchor 220 do not independently compressspecific parts of the prostate gland but an arc-shaped or a ‘U’-shapedline formed by the first anchor 210, the second anchor 220 and theligature 230 continuously compresses the prostate gland.

As shown in FIG. 7(b), the ligature 230 includes a fixed end 231 joinedto the first anchor 210, a length-adjustable loop 233 joined to thesecond anchor 220, the free end 237 connected to an end portion of thelength-adjustable loop 233, and a slip knot 235 for tying the free end237 and the length-adjustable loop 233.

The fixed end 231 is tied to the first thread hole 211 and the secondthread hole 213 of the first anchor 210 to be fixed in position. Thelength-adjustable loop 233 is inserted into the first thread hole 221 ofthe second anchor 220, and then exits through the second thread hole 223of the second anchor 220 to be formed in a loop shape. Thelength-adjustable loop 233 is formed between the fixed end 231 and thefree end 237 by the slip knot 235.

As shown in FIG. 7(C), because the first anchor 210 joined to the fixedend 231 is fixed in position when the free end 237 is pulled, thelength-adjustable loop 233 gets shorter so as to compress the prostategland surrounded by it.

As shown in FIG. 8, when the first anchor 210 and the second anchor 220are arranged outside the prostate lobes A and B, the ligature 230 isarranged loosely. In the above state, when the operator rotates a winderhandle 520 to wind the free end 237 on the winder gear 530, the free end237 gets shorter and the length-adjustable loop 233 also gets shorter soas to compress the prostate lobes A and B.

That is, as shown in FIG. 19(b), when the first anchor 210 and thesecond anchor 220 are arranged outside the prostate gland, the ligature230 is connected loosely. When the operator pulls the free end 237 usingthe winder handle 520 to tighten the ligature 230, as shown in FIG.19(c), the first anchor 210, the second anchor 220 and the ligature 230continuously surround and compress the prostate lobes A and B. Becausethe first anchor 210 and the second anchor 220 are connected with eachother by the ligature 230, the space between the first anchor 210 andthe second anchor 220 is also compressed continuously so that theurethra (C) is opened.

The sheath 300 guides the anchor assembly 200 toward the prostate lobesA and B with the needle 350. As shown in FIGS. 5 and 6, the rear end ofthe sheath 300 is combined with the handle frame part 100, and the frontend extends from the handle frame part 100 to a predetermined length andis inserted into the urethra (C) through an outer sheath (S).

As shown in FIGS. 18 and 19, the operator inserts a transurethralendoscope 600 into the sheath 300 inserted into the urethra (C) throughthe outer sheath (S) in order to inspect the inside of the prostategland, and manipulates the benign prostatic hyperplasia treatment deviceso that the needle 350 penetrates the prostate lobes A and B and a pairof the anchors 210 and 220 is arranged outside the prostate lobes A andB.

The sheath 300 is formed in a tubular shape with a predetermined length,and includes: a sheath body 300 a formed by a needle insertion tube 310,an endoscope insertion tube 320 and a blade shaft movement tube 330combined integrally; a needle guide member 340 disposed at the front endof the sheath body 300 a to guide the needle 350 toward the prostatelobes A and B; the needle 350 accommodated in the needle insertion tube310 to guide the anchor assembly 200 to the prostate lobes A and B; apusher 360 inserted into the rear end of the anchor assembly 200 insidethe needle 350 to push the anchor assembly 200 toward the front end ofthe needle; a needle blade part 370 disposed below the needle guide part340 to be movable in the back-and-forth direction in order to cut theligature 230; and a sheath fixing member 380 for joining the sheath 300to the handle frame part 100.

The needle 350 is accommodated in the needle insertion tube 310, and theendoscope insertion tube 320 is disposed integrally with a lower portionof the needle insertion tube 310 to provide a passage through which theendoscope 600 moves. The blade shaft movement tube 330 is integrallycombined with a lower portion of the endoscope insertion tube 320 toprovide a passage through which a blade plate connecting shaft 373moves.

The sheath body 300 a is formed by a vertical combination of the needleinsertion tube 310, the endoscope insertion tube 320 and the blade shaftmovement tube 330 as shown in FIG. 4. The rear end of the sheath body300 a is inserted into a sheath insertion hole 411 c of the needleholder 410. In this instance, as shown in FIG. 5, the endoscopeinsertion tube 320 is longer than the needle insertion tube 310 and theblade shaft movement tube 330, and an end portion 320 a of the endoscopeinsertion tube 320 is arranged outside the needle holder 410.

Moreover, as shown in FIG. 6, the transurethral endoscope 600 isinserted into the end portion 320 a of the endoscope insertion tube 320and a transurethral endoscope inlet 610 is arranged at the end portion320 a.

The needle 350 is inserted into the rear end of the needle insertiontube 310, and the pusher 360 is assembled through the rear end. Theneedle guide member 340 is detachably combined with the front ends ofthe needle insertion tube 310 and the blade shaft movement tube 330.

Here, as shown in FIG. 1, the components of the sheath 300, the handleframe part 100, the anchor assembly 200, the needle manipulating part400, and the thread winder 500 are completely assembled and aresterilized and packaged by a manufacturing company to be provided tohospitals. Therefore, the benign prostatic hyperplasia treatment deviceaccording to the embodiment of the present invention is improved in userconvenience since the operator can use it as it is without the need todisassemble or assemble the components during the surgical operation.

FIG. 9 is a view showing a front end structure of the sheath 300. Asshown in FIG. 9(a), the needle guide member 340 includes a guide body341, a needle insertion tube connecting tube 342 which protrudesrearwards from the guide body 341 and is combined with the needleinsertion tube 310, and a blade shaft connecting tube 345 combined withthe blade shaft movement tube 330.

The needle guide member 340 is fixed in position when the needleinsertion tube connecting tube 342 and the blade shaft connecting tube345 are respectively combined with the needle insertion tube 310 and theblade shaft movement tube 330. A needle exposure hole 344 for exposingthe needle 350 externally is formed between the needle insertion tubeconnecting tube 342 and the blade shaft connecting tube 345. Thetransurethral endoscope 600 moved into the endoscope insertion tube 320may be exposed into the urethra (C) through the needle exposure hole344.

Furthermore, the ligature 230 accommodated in the needle 350 is exposedexternally through the needle exposure hole 344, and the ligature 230can be moved to the prostate lobes A and B without interruption.

A needle outlet 346 for discharging the needle 350 externally is formedat an upper portion of the blade shaft connecting tube 345. A bladeplate 371 of the needle blade part 370 is joined to the needle outlet346 to be slidably movable.

A needle guide curved surface 343 for guiding the needle 350 to theurethra (C) is formed on the inner wall of the upper portion at whichthe needle exposure hole 344 is formed. The needle 350 is arrangedinside the needle insertion tube 310 in an initial state as shown inFIG. 9(b). When the operator manipulates the needle trigger 420, asshown in FIG. 9(a), the needle 350 is extended externally to apredetermined length through the needle guide member 340.

In this instance, the needle 350 is bent at a predetermined angle alongthe curved surface of the needle guide curved surface 343 and penetratesthe prostate lobes A and B.

The needle 350 has a predetermined length, is inserted into the needleinsertion tube 310, and is guided into the prostate lobes A and Bthrough the needle guide member 340 when the operator manipulates theneedle trigger 420.

The needle 350 may be made of metal or metal alloy, preferably, nitinol.The needle 350 is manufactured to be curved at the front end. The needle350 is located on the needle guide curved surface 420 when beingaccommodated in the needle insertion tube 310, so as to elasticallymaintain the curved form corresponding to the curvature of the needleguide curved surface 343. When the needle is deployed by the needletrigger 420 and is deployed into the prostate lobes A and B through theneedle guide member 340, the needle 350 is adjusted in terms of itsdeployment angle by the needle guide curved surface 343 and is curved tomatch the curvature formed when being manufactured.

As shown in the enlarged view of FIG. 6, a needle slot 351 for exposingthe ligature 230 of the anchor assembly 200 externally is formed at thefront end of the needle 350 deployed through the needle outlet 346. Thelength of the needle slot 351 is set to be equal to or less than the sumof lengths of the first anchor 210 and the second anchor 220. In oneinstance, if the first anchor 210 and the second anchor 220 are 8 mm inlength, the needle slot 351 is 16 mm in length and 0.4 mm in width. Inthis instance, the needle slot 351 can get inwardly narrower from thefront end.

The pusher 360 is arranged at the rear end of the needle 350, pushes thefirst anchor 210 and the second anchor 220 in consecutive order when theneedle 350 penetrates the tissues of the prostate lobes A and B, so thatthe first anchor 210 and the second anchor 220 are released from theneedle 350.

As shown in FIG. 5, the pusher 360 includes: a pusher shaft 361 insertedinto the needle 350; a pusher holder 363 formed at the rear end of thepusher shaft 361 to a predetermined length and inserted into the needleholder 410; a pusher button shaft 365 extending at right angles to therear end of the pusher shaft 361; a pusher button 366 formed at an endportion of the pusher button shaft 365 to occupy a predetermined areaand manipulated by the operator; and a pusher tail 367 protrudingupwards at the front end of the pusher shaft 361 to fix the position ofthe pusher shaft 361.

The pusher shaft 361 is inserted into the needle 350, and is located atthe rear end of the second anchor 229 as shown in the enlarged view ofFIG. 6. The pusher shaft 361 pushes the second anchor 220 to push thefirst anchor 210 and the second anchor 220 out of the needle 350 whenthe operator moves the pusher shaft 361 forwards using the pusher button366.

The pusher holder 363 is accommodated between a horizontal bar 411 ofthe needle holder 410 and an upper combining bar 415. The pusher holder363 extends from the rear end of the pusher shaft 361 to a predeterminedlength to support back-and-forth movement of the pusher shaft 361.

The pusher button shaft 365 extends from a boundary area of the pushershaft 361 and the pusher holder 363 to pusher movement slits 112 and 121of the left frame 110 and the right frame 120. The pusher button 366 isjoined to an end portion of the pusher button shaft 365 extended out ofthe left and right pusher movement slits 112 and 121.

As shown in FIG. 2, the operator presses the pusher button 366, which isextended out of the pusher movement slits 112 and 121 of the handleframe part 100, in the back-and-forth direction in order to adjust theposition of the pusher shaft 361.

As shown in FIG. 10(a), when the pusher button 366 is located at therearmost end of the pusher movement slits 112 and 121, the pusher shaft361 is pushed back and the first anchor 210 and the second anchor 220are all accommodated in the needle 350 as shown in FIG. 16(a).

As shown in FIG. 15(c), when the operator pushes the pusher button 366forwards, the pusher shaft 361 pushes the second anchor 220 as much asthe pusher button is moved so as to push the first anchor 210 out of theneedle 350 as shown in FIG. 16(b).

Here, the pusher tail 367 limits the displacement of the pusher button366 moved by the operator to be as long as the length of the anchors 210and 220.

FIG. 11(b) is a perspective view showing a combination structure of theneedle holder 410 and the pusher 360. A tail position fixing rail 416 isformed on the upper surface inside the upper combining bar 415 of theneedle holder 410 to correspond to the length of the needle slot 351.Additionally, a first groove 416 a, a second groove 416 b and a thirdgroove 416 c are formed to be upwardly hollow and are spaced apart fromone another at intervals corresponding to the length of the anchors 210and 220.

When the operator moves the pusher button 366, the pusher tail 367 iscaught and joined to the first groove 416 a, the second groove 416 b andthe third groove 416 c in consecutive order, and limits the displacementof the pusher shaft 361 by the length of the anchors 210 and 220.

Therefore, when the pusher tail 367 is located at the first groove 416a, the first anchor 210 and the second anchor 220 are all accommodatedin the needle 350. When the operator presses the pusher button 366 tomove the pusher shaft 361 forwards so that the pusher tail 367 islocated at the second groove 416 b, the first anchor 210 is push ed outof the needle 350. Moreover, when the operator moves the pusher shaft361 forwards so that the pusher tail 367 located at the second groove416 b is now located at the third groove 416 c, as shown in FIG. 17, thepusher shaft 361 is moved to the front end of the needle 350 and thesecond anchor 220 is push ed out of the needle 350.

When the first anchor 210 and the second anchor 220 are deployed andarranged on the outer surfaces of the prostate lobes A and B, the needleblade part 370 serves to cut the free end 237 of the ligature 230 thathas been adjusted in length.

As shown in FIG. 5, the needle blade part 370 includes: the blade plate371 slidably joined to the needle outlet 346 of the needle guide member340; a blade plate connecting shaft 373 extending from the blade plate371 to the handle frame part 100; and a blade pressing button 375disposed at the rear end of the blade plate connecting shaft 373.

The blade plate 371 is disposed at the needle outlet 346, is moved backand forth by the blade plate connecting shaft 373, and cuts the free end237 of the ligature 230.

As shown in FIG. 19(b), when the first anchor 210 and the second anchor220 released from the needle 350 are located on the outer surface of theprostate gland, the free end 237 of the ligature 230 is connected to thethread winder 500 of the handle frame part 100 through the needleinsertion tube 310. The free end 237 extends through the needleinsertion tube 310 in the space next to the needle 350 and is connectedto the thread winder 500.

The operator rotates the winder handle 520 of the thread winder 500 towind the free end 237, and shortens the length-adjustable loop 233 ofthe ligature 230 surrounding the prostate lobes A and B. In thisinstance, the blade plate 371 is moved and cuts the ligature 230 thathas been adjusted in length.

As shown in the enlarged view of FIG. 5, the blade plate 371 is formedin a plate shape with an area which is slidably movable in the needleoutlet 346. A needle discharge hole 371 a for discharging the needle 350is formed inside the blade plate 371. Moreover, a blade slit 371 b isformed at an upper portion of the needle discharge hole 371 a.

The blade slit 371 b is formed to get narrower, and inner end portionswhich face each other are formed to be sharp.

As shown in FIG. 9(b), when the operator pulls the blade plateconnecting shaft 373 backwards, the blade plate 371 slides backwards,and the ligature 230 is inserted into the blade slit 371 b. Then, theblade slit 371 b, which is narrow and sharp, and the ligature 230 comeinto contact, and the free end 237 of the ligature 230 is cut.

The blade plate connecting shaft 373 extends to the blade buttonmovement slits 114 and 123 of the handle frame part 100 through theblade shaft movement tube 330. The blade plate connecting shaft 373transfers the back-and-forth movement of the blade pressing button 375by the operator to the blade plate 371.

The blade pressing button 375 protrudes externally from the left andright blade button movement slits 114 and 123 of the handle frame part100 and is moved back and forth by the operator.

Before the anchors 210 and 220 are released from the needle 350, asshown in FIG. 2, the blade pressing button 375 is located at the frontof the blade button movement slits 114 and 123. On the other hand, inorder to cut the free end 237 of the ligature 230 after the first anchor210 and the second anchor 220 are all located on the prostate lobes Aand B, the operator moves the blade pressing button 375 to the back ofthe blade button movement slits 114 and 123 as shown in FIG. 10(a).

Therefore, as shown in FIG. 9(b), the blade plate 371 is pulledbackwards and cuts the ligature 230.

The blade plate 371 is accommodated in the needle guide member 340, andthe blade plate connecting shaft 373 is connected to the blade pressingbutton 375 and is combined with the handle frame part 100.

The sheath fixing member 380 combines the sheath 300 with the handleframe part 100. As shown in FIG. 4, the sheath fixing member 380includes: a sheath combining plate 381 forcibly inserted into a sheathcombining plate insertion groove 119 of the handle frame part 100; asheath combining tube 383 into which the sheath 300 is inserted; and afixing ring 385 fixed between the sheath combining tube 383 and thesheath combining plate 381.

The sheath combining plate 381 is fixed in position by being insertedinto the sheath combining plate insertion groove 119 of the handle framepart 100. A plurality of combining protrusions 381 a are formed on thefront surface of the sheath combining plate 381. The sheath 300 isinserted into the sheath combining tube 383. A plurality of protrusioninsertion holes (not shown) into which the combining protrusions 381 aare inserted are formed in the rear surface of the sheath combining tube383.

The sheath 300 penetrates through the sheath combining tube 383 and thesheath combining plate 381 in consecutive order, and is inserted intothe sheath insertion hole 411 c of the needle holder 410. The sheathcombining tube 383 is fixed in position by being joined to the combiningprotrusions 381 a of the sheath combining plate 381.

The fixing ring 385 is fixed between the sheath combining tube 383 andthe sheath combining plate 381. As shown in FIG. 18, during the surgicaloperation, the fixing ring 385 is used to fix the outer sheath (S) onthe outer face of the sheath body 300 a.

The outer sheath (S) is fixed to the outer face of the sheath body 300 aby being caught and joined to a locking hook 385 a of the fixing ring385.

The needle manipulating part 400 adjusts the positions of the needle 350and the anchor assembly 200 in steps so that the needle 350 is deployedout of the sheath 300 and the anchor assembly 200 is released from theneedle 350 and is arranged in the prostate lobes A and B.

As shown in FIGS. 4 and 5, the needle manipulating part 400 includes:the needle holder 410 for adjusting the position of the needle 350; theneedle trigger 420 for discharging the needle 350 out of the needleguide member 340 by elastically firing the needle holder 410; an elasticholder support part 430 for providing elastic force to deploy the needleholder 410 by the user's manipulation of the needle trigger 420; and atrigger locking member 440 for locking the needle trigger 420.

The needle holder 410 is moved forwards by the needle trigger 420 andthe elastic holder support part 430, and the needle 350 is deployedthrough the needle guide member 340 and penetrates the prostate lobes Aand B. The needle holder 410 includes: the horizontal bar 411 formedhorizontally; the pulling lever 413 extending downwards from the frontend of the horizontal bar 411 to a predetermined length and pressed bythe operator; and the upper combining bar 415 combined with the upperportion of the horizontal bar 411 in the state where the needle 350 isfixed.

The endoscope insertion tube 320 of the sheath 300 is accommodated inthe horizontal bar 411. Holder position adjusting teeth 411 a are formedat a lower portion of the horizontal bar 411 in a longitudinaldirection. The holder position adjusting teeth 411 a engage with holderposition fixing teeth 421 a of the needle trigger 420 so as to adjustthe position of the needle holder 410 inside the handle frame part 100.A pusher button movement rail 411 b of a predetermined length is formedon the upper portion of the horizontal bar, and the sheath insertionhole 411 c into which the sheath 300 is inserted is formed at the frontof the horizontal bar 411.

The pulling lever 413 extends downwards from the horizontal bar 411 to apredetermined length, and as shown in FIG. 2, is extended out of thehandle frame part 100. When the operator pulls the exposed pulling lever413 with the hand, the needle holder 410 that has been moved forwards bythe operator's manipulation of the needle trigger 420 adjusts itsposition to be returned to the back.

As shown in FIG. 4, a support shaft insertion hole 413 a into which anelastic member support shaft 431 of the elastic holder support part 430is inserted is formed at the front of the pulling lever 413. Therefore,the pulling lever 413 moves back and forth along the elastic membersupport shaft 431.

The upper combining bar 415 is combined with the upper portion of thehorizontal bar 411 to form the pusher button movement rail 411 b. Thepusher button movement rail 411 b is formed at a location correspondingto the left and right pusher movement slits 112 and 121 of the handleframe part 100, and the pusher button shaft 365 is accommodated thereinto be movable.

The tail position fixing rail 416 described above is formed inside theupper combining bar 415 to adjust the displacement of the pusher 360.

The needle trigger 420 fixes the needle holder 410 in place or releasesthe fixed state of the needle holder 410 so that the needle holder 410can be deployed forwards by elastic force of the elastic holder supportpart 430.

As shown in FIGS. 5 and 12, the needle trigger 420 includes: a holderremovable bar 421 attached to or detached from the needle holder 410; aframe support bar 425 formed at a lower portion of the holder removablebar 421 to be inclined; a trigger rotating shaft 423 combined with thehandle frame part 100 so that the needle trigger 420 can be rotated; anda trigger return spring 426 providing elastic force so that the triggerrotating shaft 423 is rotated in the direction that the holder removablebar 421 is combined with the needle holder 410.

The holder removable bar 421, with a pivot at the trigger rotating shaft423, is formed to be aligned with the horizontal bar 411 of the needleholder 410, and the holder position fixing teeth 421 a is formed on theupper surface of the front end. As shown in FIG. 12(a), the holderposition fixing teeth 421 a engage with the holder position adjustingteeth 411 a of the needle holder 410 to fix the position of the needleholder 410.

As shown in FIG. 12(b), when the needle trigger 420 is rotated about thetrigger rotating shaft 423, the holder position fixing teeth 421 a isseparated from the holder position adjusting teeth 411 a so that it isno longer attached to the needle holder 410. Therefore, the needleholder 410 is deployed forwards by elastic force of the elastic member433 of the elastic holder support part 430 and is moved.

The frame support bar 425 is combined with the trigger return spring426, so that elastic force of the trigger return spring 426 istransferred to the trigger rotating shaft 423 and the holder removablebar 421. The trigger return spring 426 has one end fixed to the framesupport bar 425 and the other end combined with a frame fixing member426 a.

The trigger return spring 426 provides elastic force so that the triggerrotating shaft 423 is rotated in the direction that the holder removablebar 421 is fixed with the needle holder 410.

A trigger manipulation button 427 with a predetermined area is formed atthe rear end of the frame support bar 425. As shown in FIG. 2, thetrigger manipulation button 427 is extended out of the rear end of thehandle frame part 100 and is pressed by the operator. When the operatorpresses the trigger manipulation button 427 upwards, the holderremovable bar 421 is rotated as shown in FIG. 12(b), the holder positionfixing teeth 421 a is separated from the holder position adjusting teeth411 a, and the needle holder 410 is moved forwards.

A locking shaft receiving ring 429 is formed between the frame removablebar 425 and the trigger manipulation button 427. The locking shaftreceiving ring 429 has an open end and the trigger locking member 440 isaccommodated therein.

As shown in FIG. 12(a), when the trigger locking member 440 isaccommodated in the locking shaft receiving ring 429, rotation of theneedle trigger 420 is limited. Therefore, the needle holder 410 canremain fixed in position.

On the other hand, as shown in FIG. 12(b), when the trigger lockingmember 440 is separated from the locking shaft receiving ring 429, theoperator can manipulate the trigger manipulation button 427 to rotatethe needle trigger 420.

The trigger locking member 440 is disposed to be movable horizontallyalong the locking member movement grooves 115 and 125 of the handleframe part 100. In this instance, the positions of the rear ends of themovement grooves 115 and 125 are formed to correspond to the position ofthe locking shaft receiving ring 429 of the needle trigger 420.

Therefore, as shown in FIG. 15(b), as soon as the trigger locking member440 is located at the back of the movement grooves 115 and 125, thetrigger locking member 440 is accommodated in the locking shaftreceiving ring 429. On the other hand, as shown in FIG. 15(a), when thetrigger locking member 440 is located at the front of the movementgrooves 115 and 125, the trigger locking member 440 gets out of thelocking shaft receiving ring 429.

The elastic holder support part 430 causes the needle holder 410 to bedeployed forwards at a rapid speed and provides force for the needle 350accommodated in the needle insertion tube 310 to be deployed through theneedle outlet 346 of the needle guide member 340 and penetrate theprostate lobes A and B.

As shown in FIG. 11, the elastic holder support part 430 includes: anelastic member support shaft 431 combined with the pulling lever 413 ina widthwise direction; and the elastic member 433 combined with theelastic member support shaft 431. One end of the elastic member supportshaft 431 is accommodated in the support shaft insertion hole 413 a ofthe pulling lever 413, and a shaft fixing plate 431 a which is fixed atthe handle frame part 100 is disposed at the other end of the elasticmember support shaft 431.

The elastic member 433 is disposed between the pulling lever 413 and theshaft fixing plate 431 a to provide elastic force so that the needleholder 410 can be moved back and forth.

As shown in FIG. 12(a), when the operator pulls the pulling lever 413backwards and combines the holder position fixing teeth 421 a of theholder removable bar 421 of the needle trigger 420 with the front of theholder position adjusting teeth 411 a, the elastic member 433 iscompressed between the pulling lever 413 and the shaft fixing plate 431a.

As shown in FIG. 12(b), when the operator moves the trigger lockingmember 440 from the locking shaft receiving ring 429, the holderposition fixing teeth 421 a are free from the holder position adjustingteeth 411 a, and the elastic member 433 provides elastic force to returnto the initial position so that the needle holder 410 moves forwardsalong the elastic member support shaft 431.

As shown in FIG. 6, the needle 350 inside the needle insertion tube 310is deployed through the needle outlet 346 of the needle guide member 340and penetrates the prostate gland due to the speed of the needle holder410 moving forwards.

In this instance, the length by which the needle 350 is deployed throughthe needle outlet 346 of the needle guide member 340 by elastic force ofthe elastic member 433 is such that the needle 350 extends from theurethra (C) into the tissue of one prostate lobe A and comes out of itsouter surface.

The thread winder 500 winds the free end 237 of the ligature 230extending to the handle frame part 100 through the needle insertion tube310 and adjusts the length of the length-adjustable loop 233 so as toadjust the intensity with which the anchor assembly 200 compresses theprostate lobes A and B.

As shown in FIG. 4, the thread winder 500 is combined with the insideand the outside of thread winder receiving recess 113 of the handleframe part 100.

FIG. 13 is a view showing a structure of the thread winder 500, and FIG.14 is an exemplary view showing an operational process of the threadwinder 500.

As shown in the drawings, the thread winder 500 includes: the windershaft 510; the winder handle 520 combined with one side of the windershaft 510 and rotated by the operator; the winder gear 530 combined withthe other side of the winder shaft 510 and rotating together with thewinder shaft 510 so that the free end 237 is wound on the outercircumferential surface thereof; the thread guide cap 537 for coveringthe outer surface of the winder gear 530 and guiding the free end 237 tothe winder gear 530; the one-way rotation limit bar 540 for limiting therotational direction so that the winder gear 530 can rotate just in onedirection; and a winder handle cover 550 combined with the winder handle520.

As shown in FIGS. 10(a) and 10(b), the winder shaft 510 penetratesthrough the handle frame part 100 to be combined with the handle framepart 100, and is rotated by the winder handle 520. The winder shaft 510is fixed to the winder handle 520 and the winder gear 530, and isrotated together with the winder gear 530 accommodated in the handleframe part 100 when the operator rotates the winder handle 520.

As shown in FIG. 13(b), a first holder bar 511 and a second holder bar513 are respectively combined with the lower end and the upper end ofthe winder shaft 510. The first holder bar 511 and the second holder bar513 are combined with the winder shaft 510 in the horizontal direction.The first holder bar 511 is inserted into a holder combining groove 523of a holder combining wheel 521.

The first holder bar 511 is combined with the holder combining wheel 521so that rotation of the winder handle 520 is transferred to the windershaft 510.

The winder handle 520 and the winder handle cover 550 are combined withthe second holder bar 513 in the same way as the first holder bar 511.The operator manipulates any one of a pair of the winder handles 520 toadjust the length of the free end 237.

A protruding key 515 is disposed on the winder shaft 510. The key 515fits inside a key hole 535 a formed in a shaft insertion hole 535 of thewinder gear 530. Therefore, rotation of the winder shaft 510 istransferred to the winder gear 530.

As shown in FIG. 10(b), the winder handle 520 is combined with the outerface of the right frame 120 so that the operator can rotate it. Theholder combining wheel 521 is disposed on the outer face of the winderhandle 520 to protrude out. An internal combining member insertion hole521 a is formed in the surface of the holder combining wheel 521 so thata fastening member (not shown) for fastening the holder combining wheel521 and the winder handle cover 550 is inserted therein. The fasteningmember (not shown) is inserted into the internal combining memberinsertion hole 521 a through an external combining member insertion hole551 of the winder handle cover 550 so that the winder handle cover 550covers the outer face of the holder combining wheel 521.

The holder combining groove 523 is formed in the middle area of theholder combining wheel 521 widthwise. The first holder bar 511 of thewinder shaft 510 is inserted into the holder combining groove 523.

The winder gear 530 is accommodated in the thread winder receivingrecess 113 of the left frame 110 in the state where the winder gear 530is combined with the winder shaft 510. The winder gear 530 is formed bya vertical stacking of a one-way rotation wheel 531 and a thread windingwheel 533. The one-way rotation wheel 531 has one-way rotation limitteeth 531 a protruding from the outer circumferential surface in thecircumferential direction to be lopsided.

As shown in FIGS. 14(b) and 14(c), the one-way rotation limit teeth 531a come into contact with the one-way rotation limit bar 540, and thewinder gear 530 is rotated just in the direction that the free end 237is wound but is not rotated in the direction that the free end 237 isunwound.

The one-way rotation limit bar 540 is accommodated in the limit barreceiving groove 113 b and comes into contact with the one-way rotationwheel 531 to limit the rotational direction of the one-way rotationwheel 531. A rotation allowable incline 541, which has the sameinclination angle as the one-way rotation limit teeth 531 a, is formedat the top of a side of the one-way rotation limit bar 540, and arotation-prevention horizontal plane 543 is formed at the top.

As shown in FIG. 14(b), when the winder gear 530 is rotated in thedirection that the free end 237 is wound, namely, in thecounterclockwise direction in the drawing, the one-way rotation limitteeth 531 a move along the rotation allowable incline 541, and therotation is allowed.

On the other hand, as shown in FIG. 14(c), when the winder gear 530 isrotated in the direction that the free end 237 is unwound, namely, inthe clockwise direction in the drawing, the rotation-preventionhorizontal plane 543 is fit inside a groove between the one-way rotationlimit teeth 531 a to block the rotation.

Therefore, the winder gear 530 is always rotated just in the directionthat the length-adjustable loop 233 of the ligature 230 gets shorter.

The thread winding wheel 533 is disposed at an upper portion of theone-way rotation wheel 531, and the free end 237 of the ligature 230 isjoined to the thread winding wheel 533 to be wound on the thread windingwheel 533. A pair of thread insertion holes 533 a to which the free end237 of the ligature 230 is joined are formed in the outercircumferential surface of the thread winding wheel 533. The free end237 is inserted into one of the thread insertion holes 533 a, is passedthrough the other thread insertion hole 533 a, and then, is knotted andis fixed at the thread winding wheel 533.

In the above state, when the thread winding wheel 533 is rotated, thefree end 237 is wound on the outer circumferential surface of the threadwinding wheel 533 so that the length-adjustable loop 233 gets shorter.

The thread guide cap 537 covers the upper portion of the thread windingwheel 533 and helps prevent the free end 237 wound on the thread windingwheel 533 from being unwound. The position fixing protrusion 537 aprotrudes from one end of the thread guide cap 537 and is inserted intothe winder fixing groove 113 a so that the thread guide cap 537 is fixedin its position.

A thread movement tube 537 b is formed to be separated from the positionfixing protrusion 537 a. As shown in FIG. 14(b), the free end 237exiting the rear end of the needle insertion tube 310 is wound on thethread winding wheel 533 through the thread movement tube 537 b.

Therefore, the winder gear 530 and the thread winding wheel 533 formedintegrally with the winder gear 530 are rotated in the rotationaldirection of the winder handle 520, but the thread guide cap 537 isfixed in its position to guide the free end 237 to the thread windingwheel 533.

Now, referring to FIGS. 2 to 19, a process for surgical operation ofbenign prostatic hyperplasia using the benign prostatic hyperplasiatreatment device 1 according to the present invention will be described.

As shown in FIG. 2, the benign prostatic hyperplasia treatment device 1is sterilized and packaged in the state where it has been assembledcompletely, and a pair of the benign prostatic hyperplasia treatmentdevice 1 are prepared for the surgical operation.

That is, the needle guide member 340 is prepared in the state where itis combined with the front end of the sheath body 300 a. The needle 350is packaged in the state where it is accommodated in the sheath body 300a. The pusher shaft 361 is packaged in the state where it isaccommodated in the needle 350.

The anchor assembly 200 is loaded at the needle slot 351 of the needle350, and the fixed end 231 and the length-adjustable loop 233 is exposedout of the needle slot 351 as shown in FIG. 6. Moreover, the free end237 of the ligature 230 is guided to the back along the needle insertiontube 310 of the needle 350 and is extended from the rear of the needleinsertion tube 310 to a predetermined length.

In this instance, the free end 237 of the ligature 230 extended to therear end of the needle insertion tube 310 is connected to the threadwinding wheel 533 of the winder gear 530 as shown in FIG. 14(a).

In the preparation state before the surgical operation, as shown in FIG.10(a), the trigger locking member 440 is located at the back of thelocking member movement grooves 115 and 125, and the pusher button 366is located at the back of the pusher movement slits 112 and 121.

Therefore, as shown in FIG. 12(a), the needle holder 410 is pulled backand the holder position fixing teeth 421 a of the holder removable bar421 of the needle trigger 420 engage with the front of the holderposition adjusting teeth 411 a so that the needle holder 410 is fixed inits position.

The elastic member 433 is compressed and the trigger locking member 440is accommodated in the locking shaft receiving ring 429 so that theneedle trigger 420 is fixed in its position.

The operator carries out local anesthesia to the urethra usinganesthetic gel, spinal anesthesia or general anesthesia. As shown inFIG. 18(a), the urethra (C) is blocked by the enlarged left prostatelobe A and the enlarged right prostate lobe B.

The operator inserts the outer sheath S through a urethral meatus, andthe outer sheath S is left inserted till the surgical operation isfinished.

As shown in FIG. 18(b), the operator inserts the sheath 300 into theurethra (C) through the outer sheath 300 a inserted previously. In thisinstance, the needle 350 is in the state where it is accommodated in theneedle insertion tube 310.

As shown in FIG. 10(a), the operator moves the trigger locking member440, which is extended out of the handle frame part 100, forwards.Therefore, the trigger locking member 440 gets out of the locking shaftreceiving ring 429 of the needle trigger 420 as shown in FIG. 15(a).

In the above state, the operator inspects the inside using thetransurethral endoscope 600 inserted into the sheath 300, and checks thepositions where the anchors 210 and 220 will be placed. The positionsfor placing the anchors 210 and 220 may be determined based onanatomical points, such as the bladder neck or verumontanum.

The sheath 300 is tilted at an angle of 20 degrees or more toward theleft prostate lobe. This is just an example, and the operator can selectwhether he or she wants to treat the left or the right side firstaccording to his or her independent judgment.

Furthermore, as shown in FIG. 12(b), the operator rotates the triggermanipulation button 427 of the needle trigger 420 upwards so that theholder position fixing teeth 421 a of the holder removable bar 421 arefree from the holder position adjusting teeth 411 a of the needle holder410.

Therefore, the needle holder 410 is deployed forwards by elastic forceof the elastic member 433, and as shown in FIG. 18(c), the needle 350 isdeployed outwards from the needle guide member 340 and comes out of theprostate gland after penetrating through the prostate gland.

In this instance, as shown in FIG. 16(a), the first anchor 210 and thesecond anchor 220 are accommodated in the needle slot 351 in consecutiveorder, and the pusher shaft 361 is inserted at the rear end of thesecond anchor 220. The first anchor 210 and the second anchor 220 insidethe needle 350 are fixed in their positions unless the operator forciblyapplies force since the bent plate 217 exerts force to be bent.

The operator pushes the pusher button 366, which is extended out of thehandle frame part 100, forwards. Therefore, as shown in FIG. 15(c), thepusher button 366 moves forwards along the pusher button movement rail411 b.

In this instance, the pusher tail 367 is caught at the second groove 416b, and the operator stops applying force to the pusher button 366.

When the pusher tail 367 is caught at the second groove 416 b, thepusher shaft 361 pushes the second anchor 220 forwards, and as shown inFIG. 16(b), the first anchor 210 is released from the needle 350. Asshown in FIG. 18(d), the first anchor 210 released from the needle 350is deployed on the outer surface of the upper portion of the leftprostate lobe A.

When the deployment of the first anchor 210 is completed, the operatorpulls back the pulling lever 413 so that the holder position fixingteeth 421 a of the needle trigger 420 engage with the front of theholder position adjusting teeth 411 a. Therefore, the needle 350 isreturned to the inside of the needle guide member 340.

The operator moves the sheath 300 downwards, and moves the needle guidemember 340 to the position where the second anchor 220 will be placed.Then, the operator rotates the trigger manipulation button 427 of theneedle trigger 420 upwards to deploy the needle holder 410 forwards, andmakes the needle 350 penetrate through the lower portion of the leftprostate lobe A.

In addition, as shown in FIG. 17(a), the operator manipulates the pusherbutton 366 forwards, and the pusher tail 367 fits inside the thirdgroove 416 c. As shown in FIG. 17(b), due to the forward movement of thepusher button 366 the pusher shaft 361 pushes the rear end of the secondanchor 220 so that the second anchor 220 is released from the needle350.

As shown in FIG. 19(a), the second anchor 220 released from the needle350 is placed on the outer surface of the lower portion of the leftprostate lobe A. In this instance, the first anchor 210 and the secondanchor 220 are connected with each other by the ligature 230, and thefree end 237 is wound on the thread winder 500 through the needleinsertion tube 310.

As shown in FIG. 19(a), because the length of the length-adjustable loop233 is not adjusted in the state where the first anchor 210 and thesecond anchor 220 are placed on the outer surface of the prostate gland,the ligature 230 is positioned loosely so that the prostate tissue isnot compressed.

As shown in FIG. 19(b), the operator inspects the inside with theendoscope and rotates the winder handle 520 so that the free end 237 iswound on the thread winding wheel 533. The free end 237 is wound on thethread winding wheel 533, the length-adjustable loop 233 gets shorter,and the anchor assembly 200 compresses the left prostate lobe A.

The operator checks how the anchor assembly 200 opens the urethra (C) bycompressing the left prostate lobe A, and then, as shown in FIG. 10(b),pushes the blade pressing button 375 backwards.

As shown in FIG. 9(b), the blade plate 371 slides toward the back of theneedle outlet 346, and the free end 237 of the ligature 230 is insertedinto the blade slit 371 b of the blade plate 371 and is cut. The freeend 237 of the cut ligature 230 is 1 mm or less in length, and can beembedded in the prostate tissue. Therefore, as shown in FIG. 19(c), theanchor assembly 200 compresses the left prostate lobe A to open theprostatic urethra. Then, the surgical operation is finished.

The operator removes the sheath 300 out of the urethra, and then deploysthe anchor assembly 200 to the right prostate lobe B in the same way asthe left prostate lobe A using a new benign prostatic hyperplasiatreatment device 1.

As shown in FIG. 19(d), a pair of the anchor assemblies 200 is deployedat the left prostate lobe A and the right prostate lobe B to open theurethra C. In this instance, the anchor assemblies 200 continuouslycompress the prostate tissues in the form of a “U” character or an ovalshape connecting the first anchor 210, the second anchor 220 and theligature 230 with one another. Therefore, the length of the urethra Copened by being pressed by the ligature 230 can be adjusted and thewidth d of the urethra pressed can be also adjusted.

Meanwhile, the benign prostatic hyperplasia treatment device 1 accordingto the present invention has been described in such a way that the firstanchor 210 is deployed first and the second anchor 220 is deployedlater, but this is just an example, and as occasion demands, the secondanchor 220 may be deployed first, and then, the first anchor 210 may bedeployed later.

In the meantime, the benign prostatic hyperplasia treatment device 1according to the present invention has been described in such a way thatthe first anchor 210 is deployed at the upper portion of the prostategland and the second anchor 220 is deployed at the lower portion of theprostate gland, but this is just an example, and the second anchor 220may be deployed at the upper portion of the prostate gland and the firstanchor 210 may be deployed at the lower portion.

Meanwhile, in the benign prostatic hyperplasia treatment device 1according to the present invention, the needle holder 410 is deployed byelastic force of the elastic member 433, and the needle 350 is insertedinto the prostate gland. However, as occasion demands, the operator maypush the needle holder 410 by hand to adjust the position of the needle350.

In the meantime, FIG. 20 is a view showing an anchor assembly 200 a of abenign prostatic hyperplasia treatment device according to a firstmodification of the present invention, FIG. 21 is an exemplary viewshowing a treatment process of the anchor assembly 200 a according tothe first modification of the present invention, and FIG. 22 is anexemplary view showing a state where the anchor assembly 200 a of thebenign prostatic hyperplasia treatment device according to the firstmodification of the present invention is deployed at the left prostatelobe A.

In the case of the anchor assembly 200 according to the embodiment ofthe present invention, the first anchor 210 and the second anchor 220are respectively arranged on the outer surfaces of the prostate lobes tobe spaced apart from each other, and the length-adjustable loop 233connecting the first anchor 210 and the second anchor 220 is adjusted inlength by the slip knot 235 and continuously compresses the prostatetissue.

On the other hand, the anchor assembly 200 a according to the firstmodification of the present invention continuously compresses theprostate tissue while adjusting the length of the length-adjustable loop233 without the slip knot 235. In order to achieve the above, the anchorassembly 200 a according to the first modification of the presentinvention includes a lock anchor 240 besides the first anchor 210 andthe second anchor 220.

As shown in FIGS. 20(a) and 20(b), the anchor assembly 200 a has thefirst anchor 210 and the second anchor 220, wherein the first anchor 210is fixed at the fixed end 231, and the second anchor 220 is connected tothe fixed end 231 through the length-adjustable loop 233. Additionally,the length-adjustable loop 233 is connected to the free end 237.

The lock anchor 240 combined with the free end 237, and as shown in FIG.22, is located in the inner urethral region of the prostate lobe A in adirection opposed to the second anchor 220 to fix the position of thefree end 237.

The lock anchor 240 is made with a plate-shaped material, and has athread guide groove 241 cut inwards from an end portion. The threadguide groove 241 is formed in a “V” character so as to be graduallywider from the inside to the outside. The thread guide groove 241 has athread fixing groove 241 a formed on an inner face 241 b so that theligature 230 is fit and fixed therein.

As shown in FIG. 21(a), the lock anchor 240 is arranged inside the bladeplate 371 in parallel with the blade plate 371. The thread guide groove241 is arranged in such a way that the needle 350 is not interfered whenthe needle 250 enters the needle discharge hole 371 a and is dischargedfrom the needle discharge hole 371 a.

The lock anchor 240 maintains a state where the lock anchor 240 isjoined to the inner wall surface of the blade plate 371 till the firstanchor 210 and the second anchor 220 are located outside the prostategland. The sheath 300 is moved toward the inside of the prostate gland,namely, the urethra (C), and then, is moved to face the second anchor220. After that, as shown in FIG. 21(b), when the operator compressesthe pusher shaft 361 out of the needle 350, the lock anchor 240 on therear surface of the blade plate 371 is discharged to the urethra (C)through the needle discharge hole 371 a. In this instance, the free end237 connected with the second anchor 220 is guided to the thread guidegroove 241 of the lock anchor 240 to be inserted into the thread fixinggroove 241 a.

After checking that the lock anchor 240 is located inside the urethra(C) with the endoscope, the operator rotates the winder handle 520 sothat the free end 237 is wound on the thread winding wheel 533.Accordingly, the length-adjustable loop 233 gets shorter and compressesthe prostate gland to open the urethra (C). After that, the blade plate371 is moved backwards so that the free end 237 is cut.

The anchor assembly 200 a according to the first modification has thelength-adjustable loop 233 which connects the first anchor 210, thesecond anchor 220 and the lock anchor 240 with one another without usingthe slip knot 235, thereby continuously compressing a predeterminedportion of the prostate gland by adjusting the length of thelength-adjustable loop.

Meanwhile, FIG. 23 is a view showing anchor assemblies 200 b ofaccording to a second modification and a third modification of thepresent invention, and FIG. 24 is an exemplary view showing a statewhere the anchor assembly 200 b according to the second modification ofthe present invention is deployed at the left prostate lobe A and astate where the anchor assembly according to the third modification ofthe present invention is deployed at the left prostate lobe A.

In the case of the anchor assembly 200 b according to the secondmodification of the present invention, a first anchor 210 is arrangedoutside the prostate lobe A, and a second anchor 220 a is arranged toface the inside of the prostate lobe A, namely, the urethra (C). An endof the length-adjustable loop 233 is combined to surround the inside ofthe first thread coupling hole 211 and a second thread coupling hole 213of the first anchor 210, and the other end extends to the second anchor220 a. The other end of the length-adjustable loop 233 is connected withthe free end 237 below the second anchor 220 a by the slip knot 235.

The second anchor 220 a as a thread coupling groove 221 a formed in around ring shape on the plate surface thereof so that thelength-adjustable loop 233 penetrates downwards to be connected with thefree end 237.

As shown in FIG. 24(a), the first anchor 210 is arranged outside theprostate lobe A, and the second anchor 220 a is arranged inside theprostate lobe A. when the free end 237 is wound, the length-adjustableloop 233 connected with the slip knot 235 gets shorter, and the secondanchor 220 a compresses the prostate tissue to open the urethra. In thisinstance, the length-adjustable loop 233 is located inside a penetrationpath D through which the needle 350 passes.

Meanwhile, compared with the anchor assembly 200 b according to thesecond modification of the present invention, the anchor assembly 200 caccording to the third modification of the present invention has theslip knot 235 located between the first anchor 210 and the second anchor220 a.

The first anchor 210 is fixed by the fixed end 231, and thelength-adjustable loop 233 extends to be wound on the thread couplinggroove 221 a of the second anchor 220 a is connected with the free end237 through the slip knot 235.

As shown in FIG. 24(b), when the operator pulls the free end 237, thelength-adjustable loop 233 gets shorter, and the second anchor 220 acompresses the prostate tissue to open the urethra.

In the meantime, FIG. 25 is a view showing an anchor assembly 200 d ofaccording to a fourth modification of the present invention, and FIG. 24is an exemplary view showing a state where the anchor assembly 200 daccording to the fourth modification of the present invention isdeployed at the left prostate lobe A.

In the case of the anchor assembly 200 d according to the fourthmodification of the present invention, the fixed end 231 of the ligature230 is fixed to the second anchor 220, and the length-adjustable loop233 is joined to the first anchor 210. The length-adjustable loop 233 isconnected with the free end 237 by the slip knot 235 between the firstanchor 210 and the second anchor 220.

In the case of the anchor assembly 200 d according to the fourthmodification of the present invention, only the first anchor 210 isaccommodated in the needle 350, and the second anchor 220 is locatedinside the blade plate 371 or at an entrance of the sheath 300 in asemifixed state.

When the operator deploys the first anchor 210 outside the prostate lobeA and rotates the winder handle 520 to wind the free end 237 on thethread winding wheel 533, the free end 237 gets shorter and thelength-adjustable loop 233 is pulled. So, the second anchor 220 isdischarged out of the sheath 300 and is located inside the prostate lobeA by power pulling the length-adjustable loop 233.

In the above state, when the operator pulls the free end 237 to make thelength-adjustable loop 233 shorter, the second anchor 220 is pressed tocompress the prostate lobe A, thereby opening the urethra (C).

As described above, compared with the conventional treatment method ofpartially compressing the prostate tissue, the benign prostatichyperplasia treatment device according to the present inventionincreases urine flow rate since the prostate tissues compressed by theligature and a pair of the anchors are continuous, and it is moreeffective for patients who have a large prostate gland.

Moreover, the benign prostatic hyperplasia treatment device according tothe present invention can adjust the intensity with which to compressthe prostate gland as much as the operator wants since the operator canadjust the length of the ligature by winding the free end of theligature.

Therefore, the benign prostatic hyperplasia treatment device accordingto the present invention can adjust how to compress the prostate glandaccording to various symptoms of the benign prostatic hyperplasiapresented by patients.

A treatment method using the benign prostatic hyperplasia treatmentdevice according to the present invention does not need generalanesthesia or long operation time like laser surgery or electricalsurgery using thermal energy.

Additionally, the benign prostatic hyperplasia treatment deviceaccording to the present invention makes quick operation time and localanesthesia possible through the simple anchor installation method, andis not accompanied by side effects, such as retrograde ejaculation,impotence or hematuria, since the prostate tissues are not cut. Inaddition, because the benign prostatic hyperplasia treatment deviceaccording to the present invention is minimally invasive, if it isineffective, a patient can have another operation any time.

The technical thoughts of the present invention have been describedhereinafter.

It is to be appreciated that those skilled in the art can change ormodify the embodiments from the above description in various ways. Evenif it is not clearly illustrated or described herein, it is to beappreciated that those skilled in the art can change or modify theembodiments from the above description in various ways without departingfrom the scope and spirit of the present invention, and such changes andmodifications belong to the scope of the present invention. While thepresent invention has been described with reference to the particularillustrative embodiments, it is not to be restricted by the embodimentsbut only by the appended claims.

[Explanation of essential reference numerals in drawings] 1: benignprostatic hyperplasia treatment device 100: handle frame part 110: leftframe 111: needle manipulating part receiving groove 112: left pushermovement slit 113: thread winder receiving recess 113a: winder fixinggroove 113b: limit bar receiving groove 113c: shaft combining hole 114:left blade button movement slit 115: left locking member movement groove116: left lever movement path 117: left endoscope insertion hole 118:trigger rotating shaft combining hole 119: sheath combining plateinsertion groove 120: right frame 121: right pusher movement slit 123:right blade button movement slit 125: right locking member movementgroove 126: right lever movement path 127: right endoscope insertionhole 200: anchor assembly 210: first anchor 211: first thread hole 213:second thread hole 215: bent slit 220, 220a: second anchor 221a: threadcoupling groove 230: ligature 231: fixed end 233: length-adjustable loop235: slip knot 237: free end 240: lock anchor 241: thread guide groove241a: thread fixing groove 241b: inner face 300: sheath 310: needleinsertion tube 320: endoscope insertion tube 330: blade shaft movementtube 340: needle guide member 341: guide body 342: needle insertion tubeconnecting tube 343: needle guide curved surface 344: needle exposurehole 345: blade shaft connecting tube 346: needle outlet 350: needle351: needle slot 360: pusher 361: pusher shaft 363: pusher holder 365:pusher button shaft 366: pusher button 367: pusher tail 370: needleblade part 371: blade plate 371a: needle discharge hole 371b: blade slit373: blade plate connecting shaft 375: blade pressing button 380: sheathfixing member 381: sheath combining plate 381a: combining protrusion383: sheath combining plate 383a: hook locking ring 385: fixing ring385a: locking hook 400: needle manipulation part 410: needle holder 411:horizontal bar 411a: holder position adjusting teeth 411b: pusher buttonmovement rail 411c: sheath insertion hole 413: pulling lever 413a:support shaft insertion hole 415: upper combining bar 416: tail positionfixing rail 416a: first groove 416b: second groove 416c: third groove420: needle trigger 421: holder removable bar 421a: holder positionfixing teeth 423: trigger rotating shaft 425: frame support bar 425a:elastic member combining rib 426: trigger return spring 426a: framefixing member 427: trigger manipulation button 429: locking shaftreceiving ring 430: elastic holder support part 431: elastic membersupport shaft 431a: shaft position fixing plate 433: elastic member 440:trigger locking member 500: thread winder 510: winder shaft 511: firstholder bar 513: second holder bar 515: key 520: winder handle 521:holder combining wheel 521a: internal combining member insertion hole523: holder combining groove 530: winder gear 531: one-way rotationwheel 531a: one-way rotation limit teeth 533: thread winding wheel 533a:thread insertion hole 535: shaft insertion hole 535a: key hole 537:thread guide cap 537a: position fixing protrusion 537b: thread movementtube 540: one-way rotation limit bar 541: rotation allowable incline543: rotation-prevention horizontal plane 550: winder handle cover 551:external combining member insertion hole 600: transurethral endoscope610: transurethral endoscope inlet A, B: prostate lobe C: urethra S:outer sheath

What is claimed is:
 1. A benign prostatic hyperplasia treatment devicecomprising: anchor assemblies including a first anchor arranged at theouter surface of the prostate gland, which obstructs the prostaticurethra, a second anchor arranged inside the prostate gland to beopposed to the first anchor, and a ligature connecting the first anchorand the second anchor with each other so that the second anchorcompresses the prostate tissue to secure the opening of the prostaticurethra; a sheath inserted into the urethra and having a needle, whichguides the anchor assembly to be deployed at the prostate gland; aneedle manipulation part for manipulating movement of the needle so thatthe needle is deployed through an end portion of the sheath; a threadwinder disposed at one side of the needle manipulation part and windingthe ligature thereon to adjust intensity with which the anchorassemblies compress the prostate gland; and a handle frame part whichsupports the end portion of the sheath, the needle manipulation part andthe thread winder and is grasped by an operator, wherein the ligatureincludes: a length-adjustable loop joined to the first anchor and thesecond anchor to be adjustable in length; a free end extending from thelength-adjustable loop; and a slip knot for connecting thelength-adjustable loop to the free end so as to adjust the length of thelength-adjustable loop, and wherein the thread winder winds the free endto adjust the length of the length-adjustable loop so that the secondanchor compresses the prostate tissue.
 2. The benign prostatichyperplasia treatment device according to claim 1, wherein the slip knotis formed below the second anchor or is formed between the first anchorand the second anchor.
 3. The benign prostatic hyperplasia treatmentdevice according to claim 1, wherein the first anchor is accommodated inthe needle, and the second anchor is joined to an entrance region of thesheath.